RANGE SPINAL SYSTEM (MESA AND DENALI)

Orthosis, Spondylolisthesis Spinal Fixation

K2M, INC.

The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Range Spinal System (mesa And Denali).

Pre-market Notification Details

• Device ID: K121016
• 510k Number: K121016
• Device Name: RANGE SPINAL SYSTEM (MESA AND DENALI)
• Classification: Orthosis, Spondylolisthesis Spinal Fixation
• Applicant: K2M, INC. 751 MILLER DR., S.E., SUITE F1 Leesburg, VA 20175
• Contact: Nancy Giezen
• Correspondent: Nancy Giezen; K2M, INC. 751 MILLER DR., S.E., SUITE F1 Leesburg, VA 20175
• Product Code: MNH
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-04-04
• Decision Date: 2012-06-27
• Summary: summary

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